Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study

Novartis Vaccines4,529 enrolled

Overview

The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.

Study Type

OBSERVATIONAL

Enrollment

4,529

Conditions

Influenza

Interventions

Non-intervention observational studyOTHER

Non-intervention observational study

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome * Consents to participate in the study Exclusion Criteria: * Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest * Does not consent to participate in the study * Has received a non-Novartis pandemic influenza vaccinee

Locations (17)

Unnamed facility

Buenos Aires, Argentina

Unnamed facility

Córdoba, Argentina

Unnamed facility

Villa Nueva, Argentina